Inflammatory bowel disease (IBD) is a chronic inflammation of the gastrointestinal (GI) tract that encompasses Crohn’s disease (CD) and ulcerative colitis (UC). An estimated 3 million Americans have IBD, causing significant financial burden that can reach upward of tens of thousands of dollars in direct annual costs per patient. Most IBD patients receive their diagnoses when they are between 15 and 35 years of age, although people older than 65 years of age may have a late diagnosis. The pathogenesis of IBD is multifactorial and includes genetic susceptibility, gut microbiome changes, and external environment triggers, such as smoking, geographic location, and medications.

CD can affect the GI tract at any location from the mouth to the anus, and includes transmural and often patchy inflammation. UC, however, is limited to the colon and rectum, with continuous and superficial inflammation. Upon presentation, common IBD symptoms may include long-term diarrhea, hematochezia, abdominal pain, and weight loss. Depending on the type of IBD, uncontrolled disease can lead to complications such as perforated bowel, malnutrition, fistulas, strictures, and abscesses.

The ultimate goal of IBD treatment is to improve quality of life by reducing symptoms, limiting steroid use, and inducing and maintaining remission. Maintaining remission aids in GI mucosal healing to reduce surgery, colorectal cancer risk, and other severe complications. Treatment options depend on the patient’s disease severity and whether the condition is CD or UC. Treatment options for mild to moderate disease include aminosalicylates (sulfasalazine, mesalamine products), thiopurine (azathioprine, 6-mercaptopurine), or methotrexate monotherapy. If the disease is moderate to severe, the goal is to induce remission quickly to prevent complications. A short course (<8 weeks) of steroids and/or starting on a biologic or targeted synthetic therapy is recommended in these patients. (See Table 1 for more information on biologic treatment options and Table 2 for oral targeted treatment options.) Reference the drug package inserts for important monitoring recommendations. Being a patient advocate and providing close monitoring throughout all stages of treatment are vital for medication access and the safety of the patient, which is why uniting specialty pharmacy practices and IBD is of utmost importance.

Specialty medication approvals have had exponential growth and continue to expand the treatment options for many different disease states. Specialty pharmacy plays an integral role in treating patients with IBD, as the medications used to treat the disease are complex, expensive, not without risk, and often lifelong. Furthermore, we can expect a growing number of new medication approvals within already existing classes, new formulation approvals for existing medications, and unique class medication approvals for the treatment of IBD in the pipeline. Due to these continuous rapid advances in treatment, guidance on treatment selection and medication hierarchy is lacking because of the absence of sufficient data/head-to-head trials and outdated guidelines. It is critical for specialty pharmacists to utilize their clinical judgment, assess patient characteristics/preferences, and apply their insurance expertise to help come up with the best treatment plan alongside the physician team.

Specialty pharmacies and institutions are held to very high standards, as we all strive to offer exceptional patient care. UF Health Jacksonville is a 695-bed private not-for-profit hospital affiliated with the University of Florida. UF Health Pharmacy – Jacksonville specialty pharmacy is a dual accredited (URAC and ACHC) specialty pharmacy embedded within the health system ambulatory pharmacy. We have three dedicated and specialty-trained technicians and six specialty pharmacists who are disease state experts in various practice areas. Our specialty practice is unique in that all our specialty pharmacists split their time between the clinical and operational areas of specialty pharmacy. Clinically, we are members of the medical teams and are embedded with the providers in most specialty clinics. We have opportunities to attend clinics and develop pharmacotherapy plans with the treatment team, order labs, answer drug information questions, interpret/educate providers on insurance preferences, and educate patients on their diseases and medications. Operationally, we staff the specialty pharmacy and are part of the on-call after-hours service. We help manage specialty technicians, monitor specialty medication work queues/reports in the dispensing system and electronic medical records, and assist with medication access, prior authorizations, and insurance issues. (See Figure 1 for an illustration of the UF Health Jacksonville IBD specialty pharmacy process that intertwines both clinical and operational pharmacy processes.) Our involvement in both clinical and operational practices helps to keep us well rounded and equipped to tackle any issue or assist with new workflow changes and trainings.

Accomplished unique initiatives at UF Health Pharmacy – Jacksonville specialty pharmacy include:

1. Space expansion for growth of business
   1. Unique packaging area with individually equipped packaging stations
   2. Separate, dedicated space for a specialty hub where the staffing specialty pharmacist and specialty technicians work
   3. Private consultation area for medication training
2. Creation of homegrown and custom specialty monitoring system through the electronic medical record system
3. Dedicated information technology staff to help with reports, data mining, system updates, and improvements to workflow
4. Committee integration/creation
   1. Quarterly Ambulatory Error Prevention Meeting encompassing retail and specialty pharmacy practices
   2. Monthly Specialty Medication Management subcommittee for medication review and access

At UF Health Pharmacy – Jacksonville, our vision to continue offering the best care possible to our patients while expanding our specialty services aligns with our organization’s mission to heal, to comfort, to educate, and to discover. Future clinical growth opportunities include expansion of the IBD center with the addition of specialized medical providers, nutritionists and social workers, as well as conducting research to show the value of pharmacists in the IBD setting. Operational growth opportunities include gaining more resources to assist with the expansion of payer contracts/data mining, and increasing the number of operational staff to assist with packaging/delivery and maintenance of specialty queues and reports.

UF Health Pharmacy – Jacksonville’s blended model is just one example of how a health system specialty pharmacy can integrate pharmacists into clinics to expand patient reach and ensure that patients have access to high-quality care.

References

1. Centers for Disease Control and Prevention. Data and Statistics. Inflammatory Bowel Disease. https://www.cdc.gov/ibd/data-statistics.htm. Accessed March 25, 2022.
2. Zhang YZ, Li YY. Inflammatory bowel disease: Pathogenesis. World J Gastroenterol. 2014;20(1):91-99.
3. Okobi OE, Udoete IO, Fasehun OO, et al. A review of four practice guidelines of inflammatory bowel disease. Cureus. 13(8):e16859.
4. Crohn’s and Colitis Foundation. Overview of ulcerative colitis. https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/overview. Accessed 9/1/2021.
5. Crohn’s & Colitis Foundation. The Facts about Inflammatory Bowel Disease. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed 9/1/21.
6. Levesque BG, Sandborn WJ, Ruel J, Feagan BG, Sands BE, Colombel JF. Converging goals of treatment of inflammatory bowel disease from clinical trials and practice. Gastroenterology. 2015;148(1):37-51.e1.
7. Humira [package insert]. Chicago, IL: AbbVie Inc.; 2021.
8. Remicade [package insert]. Horsham, PA: Janssen Biotech, Inc; 2021.
9. Cimzia [package insert]. Smyrna, GA: UCB, Inc.; 2019.
10. Simponi [package insert]. Horsham, PA: Janssen Biotech, Inc; 2018.
11. U.S. Food & Drug Administration. Purple Book Database of Licensed Biological Products. https://purplebooksearch.fda.gov/ Accessed May 13, 2022.
12. Entyvio [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2021.
13. Tysabri [package insert]. Cambridge, MA: Biogen Inc.;2021
14. Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc; 2020.
15. Xeljanz [package insert]. New York, NY: Pfizer Inc.; 2022.
16. Rinvoq [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
17. Zeposia [package insert]. Summit, NJ: Celgene Corporation; 2022.
18. Feuerstein JD, Ho EY, Shmidt E, et al. Aga clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing crohn’s disease. Gastroenterology. 2021;160(7):2496-2508.
19. American Gastroenterological Association Practice Guideline. Medical management of adult outpatients with moderate to severe lunminal crohn’s disease: clinical decision support tool. Gastroenterology. 2021;160(7):2509-2510.
20. Feuerstein JD, Isaacs KL, Schneider Y, et al. Aga clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology. 2020;158(5):1450-1461.
21. American Gastroenterological Association Practice Guideline. Pharmacological management of adult outpatients with moderate to severely active ulcerative colitis: clinical decision support tool. Gastroenterology. 2020;158(5):1462-1463.

ABOUT THE AUTHOR | Abbey Johnston, PharmD, BCACP

Abbey Johnston, PharmD, BCACP, Clinical Ambulatory Specialty Pharmacist at UF Health Jacksonville, specializes in gastroenterology, with a focus on inflammatory bowel disease, and leads a pharmacist-run hepatitis C treatment clinic. She also assists with administrative tasks of specialty pharmacy accreditation standards. She practices both as a clinical and specialty pharmacy operational pharmacist.